Clinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony

Launched by FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new therapy option called FlexPoint, which is part of a machine called the PD cycler Sleep•Safe Harmony. The goal is to see how well this technology works for patients with chronic kidney disease (CKD) who need treatment to help their kidneys. Specifically, the trial will compare the effects of treatments using FlexPoint technology versus those without it. This study is not yet recruiting participants, but it will involve adults aged 18 and older who have been on a specific type of kidney treatment called automated peritoneal dialysis (APD) for at least three months.

To join the trial, participants must meet certain criteria, such as having a properly working catheter and regularly monitored fluid status. They should also be able to understand what the study involves. However, some people may not be eligible, including those with certain medical conditions or those who have recently participated in another study. If you take part, you can expect to help researchers learn more about kidney disease treatments and potentially contribute to better care options for the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed consent signed and dated by study patient and investigator/ authorised physician
• • Minimum age of 18 years
• • CKD patients with indication for renal replacement therapy
• • Patients being treated with APD for at least 3 months
• • Patients using the sleep•safe harmony PD cycler (version 3.1)
• • Fluid status regularly monitored with Body Composition Monitor (BCM)
• • Proper functioning catheter
• • Intraperitoneal Pressure (IPP) ≤ 18 cm H2O
• • Ability to understand the nature and requirements of the study
• Exclusion Criteria:
• • Any conditions which could interference with the patient's ability to comply with the study
• • Previous participation in the same study
• • Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
• • Patients receiving polyglucose containing PD solution
• • Respiratory or abdominal wall disease deemed to contraindicate intraperitoneal fill volume (FV) manipulation
• • Patients who suffer from peritonitis/exit site infection during the last 4 weeks
• • Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
• • Life expectancy \<3 months
• • Participation in an interventional clinical study during the preceding 90 days